More Than One-third of Relevant Dollars Received by ACR Guideline Authors Go Undisclosed
Approximately 35% of relevant industry payments to U.S.-based authors of American College of Rheumatology clinical practice guidelines remain undisclosed, according to findings published in Arthritis & Rheumatology.
“This study is important because it was previously unknown whether ACR guideline authors have financial relationships with pharmaceutical companies,” Cole Wayant, BS, of the Oklahoma State University Center for Health Sciences, told Healio Rheumatology. “The importance of authors with financial relationships with industry rests on the fact that there is strong data suggesting that payments from a pharmaceutical company changes physician behavior.”
“A recent study from the National Bureau of Economic Research showed that immediately following payment from a pharmaceutical company, physicians who received the payment prescribed the drug more often than physicians without payments,” he added. “When applied to clinical practice guidelines, the implications of financial relationships with pharmaceutical companies may include more favorable recommendations for specific drugs. Before testing whether more favorable recommendations were rendered, we must first know whether conflicts exist.”
To analyze industry payments to authors of ACR clinical practice guidelines, Wayant and colleagues conducted a cross-sectional study using information catalogued in the Open Payments Database. According to the researchers, this database, which began in August 2013, includes speaking and consulting fees, education, honoraria, travel, food, research costs, grants, stock ownership and dividends. Wayant and colleagues included guidelines published during or after August 2014.
According to the researchers, the ACR’s rules require that a guideline’s principle investigator be free of conflicts of interest 1 year prior to the letter of intent deadline, and remain free of conflicts through publication as well as 1 year after. In addition, at least 51% of the guideline’s development group, voting panel and literature review team must be free of relevant conflicts 1 year prior to the letter of intent, through publication. In their analysis, Wayant and colleagues were unable to determine exact letter of intent deadlines, and so analyzed payments from the date of publication and 12 months prior. All data were extracted in parallel and blinded fashion.
The researchers identified five guidelines for analysis. The guideline on axial spondylarthritis had 27 authors, the guide on glucocorticoid-induced osteoporosis included 21 authors and another on glucocorticoid-induced rheumatoid arthritis had 26 authors. The last two guidelines, on perioperative management of antirheumatic medication and polymyalgia rheumatica, had 31 and 46 total authors respectively.
Three of these guidelines — on axial spondylarthritis as well as on glucocorticoid-induced osteoporosis and RA — recommended the use of brand-name drugs, and were thus included in the analysis of relevancy payments to authors.
According to the researchers, of the 89 total U.S.based physician authors from the five included guidelines, 56 (62.9%) received at least one payment. These 56 authors received a median of $522 (IQR, 119-2,500) and a total of $9,728,751. Among the three guidelines that recommended brand-name drugs, 19 authors received at least one industry payment relevant to the guideline recommendations, with a median relevant payment amount of $748 and a total of $1,961,362. Of the total relevant payments received, 35.7% ($699,561) remained undisclosed.
In addition, Wayant and colleagues noted gaps in the ACR’s disclosure requirements, including the lack of any policy requiring the disclosure of travel and lodging reimbursements, which constituted a large portion of payments to authors in the analysis.
In light of their findings, Wayant and colleagues made three recommendations that they believe would improve the “rigor and robustness” of ACR’s clinical practice guidelines:
- Publish the list of affected companies that are said to produce products relevant to the guideline subject matter.
- Require the disclosure of travel payments.
- Cross-reference author disclosures against the Open Payments Database and ask authors to clarify discrepancies.
“Recommendations issued by individuals with conflicts of interest govern the clinical practice of those without conflicts,” Wayant said. “The ACR guidelines are developed by a cohort of physicians who may be very unlike ‘normal’ rheumatologists. The ‘normal’ rheumatologist may not have substantial relationships with industry and their only bias may come from a meal or lecture they attend. These conflicts are much different from the conflicts seen in this study, since ACR guideline authors frequently consult, speak and do research in conjunction with industry.”
“So, it stands to reason that ACR guideline authors may interpret clinical research and formulate recommendations differently than ‘normal’ rheumatologists — and this may not be due to their ‘expert’ status,” he added. “Given what is known about the strong effect of conflicts on prescribing habits and physician behavior, one must wonder whether a conflicted author and non-conflicted author would issue similar recommendations.” – by Jason Laday
Disclosures: Wayant reports no relevant financial disclosures. Co-author Carrie Gilstrap, DO, reports advisory board membership for Janssen and Sanofi-Genzyme, as well as reimbursement from Comsort for a survey.